The molecular assay detects and differentiates Trichomonas vaginalis and/or Mycoplasma genitalium in clinical urine samples.
The reagent is used for the detection of cytokeratin 19 mRNA in surgically removed sentinel lymph nodes in order to diagnose lymph node metastasis.
The new firm will offer target enrichment assays for clinical NGS testing and develop library preparation kits for clinical tests on Illumina's sequencing platform.
The St. Louis-based firm will use the funds to develop its colorectal cancer screening test, which measures eukaryotic RNA isolated from epithelial cells in stool.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The startup, which was founded by two Washington University researchers and a Wharton MBA, is looking to take a big bite out of Cologuard's market.
The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
A diverse group of researchers and diagnostic industry participants has collaborated to produce two papers that describe and critique Lyme disease testing technologies.